Senior Quality Control, Gummy Specialist

Hims & Hers • Gilbert, AZ

2d • Onsite

About The Position

Hims & Hers is seeking an experienced Senior Quality Control Specialist, Gummies to join our Quality Unit located in Mesa, Arizona. The position of Senior Quality Control Specialist, Gummies will focus on driving continuous improvement efforts that benefit and delight the Hims customer. We are looking for a highly motivated individual to help support and report to the Quality Control Manager. The Senior Quality Control Specialist, Gummies role is responsible for the inspecting and/or testing of product(s) before, during and after compounding process(es) to ensure products align with company and regulatory standards, as well as other processes necessary to support quality operations. The position performs and leads activities in compounding suites in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, USP and operational SOPs, Assist with relevant environmental monitoring programs and batch review processes and batch review processes. Monday-Friday: Shift 6am to 2:30pm and Shift 1:30pm to 10pm

Requirements

• B.S. in chemistry, microbiology, biology, quality management, engineering, or related discipline
• 1-3 years Gummy formulation/ process control experience in a regulated environment
• 3+ years experience in the area of quality assurance/control, process/quality engineering, and/or product formulation
• 1-3 years leading process improvements within a regulated facility
• Experience using pH meter, water activity meter, Brix refractometer.
• A Pharmacy Technician license or ability to obtain one within the first six months of employment (we cover costs and will help you obtain your trainee hours).
• Working knowledge of USP-NF standards <795>, and <800> including monographs
• Excellent interpersonal skills, communication skills and technical writing
• Solid understanding of product testing including understanding best practices for testing product against defined specifications
• Solid computer skills with Word, Excel, PowerPoint, and Google platform applications.
• Excellent skills in decision making, data collection and analysis, organizing and planning.
• Working knowledge and application of statistical analysis including probability and trend analysis
• Knowledge and experience in good documentation practice and facility auditing
• Overall willingness to learn, work, and assist/train in any pharmacy related tasks and are able to adapt to fast-changing conditions

Nice To Haves

• Some occasional travel may be required.

Responsibilities

• Leads cross-functional initiatives from concept to execution of QC oversight of gummy compounding process
• Escalation management of compounding challenges to appropriate stakeholders
• Drives alignment across teams to create enhanced quality parameters related to gummy compounding.
• Perform in-process and post-production quality checks, including testing, assessing products in the compounding suites to ensure product acceptability.
• Perform line clearance, where applicable.
• Provide reports and trending data to QA management
• Support departments in reporting, handling and escalation of investigations
• Support external manufacturer non-conformance investigations to improve Quality processes.
• Support change control system to provide improvement solutions
• Support quality processes in the pharmacy – including inspections, pH meters and scale checks, non-conformance/deviation/complaint investigations, implement corrective action activities training activities, etc.
• Document & review of records: SOP generation, batch record review, COA acceptance, USP monographs, etc.
• Recommend training needs, provide reports to QC Supervisor and Lead Pharmacist to ensure compliance with quality standards
• Ensures compliance with USP <795>, USP <800> and cGMP cleaning standards, where applicable.
• Assist in audit activities with all appropriate third party audits & internal audits as required to ensure compliance.
• Assist with the management of samples to be tested with contract laboratories related to process validation.

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution

What This Job Offers

• Job Type: Full-time
• Career Level: Senior